Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 12
- 主要终点
- SDH recurrence
研究概览
简要总结
Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Middle meningeal artery (MMA) embolization has been proposed as a novel treatment of chronic SDH. The aim of this study is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical post-operative treatment in patients at high risk of post-operative recurrence.
详细描述
Introduction
chronic SDHs are some of the most frequently encountered neurosurgical emergencies. The gold standard treatment of symptomatic chronic SDHs is burr-hole surgery followed by temporary closed system drainage. Post-operative recurrence rates may be as high as 10 to 20% and are a major source of morbidity and repeated surgery. MMA embolization is a promising minimally invasive procedure recently proposed as a treatment of chronic SDH. It is hypothesized that post-operative MMA embolization may reduce recurrence rate in patients at high risk of recurrence.
Aims: the primary objective of the trial is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical treatment in patients at high risk of post-operative recurrence. Secondary objectives include evaluating the impact of post-operative MMA embolization on rate of recurrence requiring new surgery (at 6 months), rate of functional dependency (at 1 and 6 months) , mortality (at 1 and 6 months) , cumulative hospital stay duration, related to the SDH, and complication rate at 6 months.
Methods: multicenter open label randomized controlled trial. Eligible patients will be assigned either to the intervention or a control arm through blocked randomization with randomblock sizes and stratified on the center, antiplatelet/anticoagulant therapy and unilateral vs bilateral SDH. Patients in the intervention group will undergo a CT angiography scan of the supra aortic trunks, followed by MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care. Patients in the control group will receive standard medical care only. Outcomes will be evaluated at 1 and 6 months. The primary outcome measure will be the rate of chronic SDH recurrence 6 months after index burr-hole surgery, as defined bellow. In order to demonstrate a decrease in recurrence rate from 15 to 5% between the intervention and control arms with a power of 80%, bilateral global alpha risk of 5%, with two planned sequential tests according to the method of Lan & Demets, and 20% patients lost to follow-up, 342 patients are required, 171 in each arm. The primary outcome will be analyzed according to intention to treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years
- •Operated for a SDH recurrence or operated for a first episode of SDH if at least one of the following recurrence risk factors is present:
- •Chronic alcoholism defined by a daily alcohol consumption > 30g/day
- •Or liver cirrhosis
- •Or antiplatelet therapy
- •Or anticoagulant therapy
- •Or thrombocytopenia with a platelet count < 100 x10(3) per µL
- •Or surgery without use of external drain
- •With affiliation to a social security scheme
- •Having signed an informed consent form or for whom a delegate close relative or a support person has signed an informed consent
排除标准
- •SDH evacuation by craniotomy or twist-drill craniostomy rather than burr-hole surgery
- •Beyond 7 days after the index surgery (surgery for recurrent SDH or first surgery in case of a risk factor as indicated in the inclusion criteria)
- •Functionally dependant patient with an mRS score ≥ 4 before the SDH
- •Patient with a life expectancy < 6 months
- •Patient with renal failure as defined by a creatinine clearance < 30 ml/min
- •Pregnancy
- •History of allergy to a iodinated contrast agent
- •Procedure deemed unachievable under local anesthesia (because of patient agitation or discomfort for instance) in a patient with a contraindication to both conscious sedation and general anesthesia.
- •Patient refusal
- •Patient for whom follow-up is deemed problematic (living abroad or homeless for instance )
- •Patients under legal guardianship or trusteeship
研究组 & 干预措施
intervention group
MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care
干预措施: MMA embolization (Procedure)
control group
standard medical care
结局指标
主要结局
SDH recurrence
时间窗: 6 months
Rate of chronic subdural hematoma (SDH) recurrence 6 months after index burr-hole surgery, defined as: * Reappearance of a homolateral SDH with a midline shift \> 5mm or a symptomatic homolateral SDH, including leading to death * Or, the presence of a homolateral SDH \> 10mm in maximal thickness on the 6 months control head CT scan * Or, the need for repeated surgery for a homolateral SDH recurrence * Or, the need for a new hospital admission in relation to a homolateral SDH recurrence
次要结局
- disability and dependency(1 and 6 months)
- hospital stay(6 months)
- complication rates(6 months)
- repeated surgery(6 months)
- mortality(1 and 6 months)